Friday, April 18, 2008

Drug Companies Push for Easier Off-Label Rules

This morning's Wall Street Journal reports that several major drug companies are pushing the FDA to relax its requirements for off-label drug use.  Here's an excerpt:

Ten major drug companies, including Pfizer Inc.; Bayer Corp., the U.S. unit of Bayer AG; AstraZeneca PLC; and Johnson & Johnson have formed a coalition to push for looser restrictions on off-label marketing. They will submit their arguments Friday to the Food and Drug Administration, which has been soliciting comments on its proposed off-label promotion guidelines. They are represented by former FDA Chief Counsel Daniel Troy, who is working with public-relations giant APCO Worldwide Inc.

Mr. Troy's group includes patient-advocacy organizations the National Alliance on Mental Illness and the National Organization for Rare Disorders. The group supports the ability of companies to disseminate articles from peer-reviewed medical journals to physicians and hospitals to inform them of new conditions for which drugs already on the market could be used but which the FDA hasn't formally approved.

The FDA said it isn't loosening the rules for industry, but clarifying them. Randall Lutter, the agency's deputy commissioner for policy, said the guidelines mandate full disclosure of any conflict of interest by journal authors in articles used in off-label promotion.

The push for off-label changes came just as the Journal of the American Medical Association suggested in two reports that Merck & Co. played down the potential risk to Alzheimer's patients of heart attack from its now-withdrawn painkiller Vioxx, and said the company had ghostwritten many academic articles favorable to that drug.

Drug-industry worries about new rules and a chilly climate in Washington were reflected at a conference here Thursday. More than 60% of participants polled during the annual conference sponsored by drug-marketing magazine DTC Perspectives said they think Congress may move to place limits on television advertising by pharmaceutical companies. Drug makers spend about $5.4 billion annually on TV ads, according to Nielsen Monitor-Plus.

ECB

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